Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis

Rikke Ratzer, Pernille Iversen, Lars Börnsen, Tim B. Dyrby, Jeppe Romme Christensen, Cecilie Ammitzbøll, Camilla Gøbel Madsen, Ellen Garde, Mark Lyksborg, Birgit Andersen, Lars Hyldstrup, Per Soelberg Sørensen, Hartwig R. Siebner, Finn Sellebjerg

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Background: There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments.

Objective: To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS.

Methods: In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans.

Results: We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone.

Conclusion: Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS.
Original languageEnglish
JournalMultiple Sclerosis
Pages (from-to)1-9
ISSN1352-4585
DOIs
Publication statusE-pub ahead of print - 2015
Externally publishedYes

Keywords

  • Progressive multiple sclerosis
  • Methylprednisolone
  • Clinical trial
  • Osteopontin
  • Magnetization transfer ratio
  • Ccerebrospinal fluid

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